Class I - Dangerous
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Medtronic Minimally Invasive Therapies Group
Class I - Dangerous
Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Class I - Dangerous
Label does not state that the product is heparin-coated.
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Boston Scientific
Class I - Dangerous
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Boston Scientific
Class I - Dangerous
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).
Class I - Dangerous
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Degania Silicone
Class I - Dangerous
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Class I - Dangerous
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Class I - Dangerous
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Class I - Dangerous
Product was placed into distribution prior to completion of all required post sterilization release activities.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
Trumpf Medical Systems
Class I - Dangerous
The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
Class I - Dangerous
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Class I - Dangerous
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
3M Surgical Clipper Professional 9681
3M Company - Health Care Business
Class I - Dangerous
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.